Development of a Quality Risk Based Tool for the Selection of Regulatory Starting Materials for Commercial Drug Substance Manufacturing Processes

2020 ◽  
Vol 24 (11) ◽  
pp. 2762-2771
Author(s):  
John Lepore ◽  
Tariq Mahmood ◽  
Robert Hartman
Keyword(s):  
Drug Substance ◽  
Manufacturing Processes ◽  
Quality Risk ◽  
Selection Of

scholarly journals The Lean Six Sigma Algorithm—A Pathway for Decreasing the Continuous Improvement Projects Failure Rate

Proceedings ◽  
2020 ◽  
Vol 63 (1) ◽  
pp. 47
Author(s):  
Karam Al-Akel ◽  
Liviu-Onoriu Marian
Keyword(s):  
Failure Rate ◽  
Continuous Improvement ◽  
Six Sigma ◽  
Lean Six Sigma ◽  
Manufacturing Processes ◽  
Timely Manner ◽  
Improvement Project ◽  
Project Failures ◽  
Specific Order ◽  
Selection Of

Even if Lean and Six Sigma tools are available for large audiences, many of the continuous improvement projects fail due to the lack of a pathway that ensures appropriate results in a timely manner. We would like to address this universal issue by generating, testing and validating an algorithm that improves manufacturing processes in a controlled manner. With a selection of the most valuable set of tools and concepts implemented in a specific order, a guideline for successful project implementation is proposed. Decreasing the overall number of continuous improvement project failures is the main scope of our algorithm and suggested methodology.

Prediction of N-Nitrosamine Partition Coefficients for Derisking Drug Substance Manufacturing Processes

2021 ◽  
Vol 25 (4) ◽  
pp. 871-883
Author(s):  
Ian W. Ashworth ◽  
Timothy T. Curran ◽  
J. Gair Ford ◽  
Simone Tomasi
Keyword(s):  
Partition Coefficients ◽  
Drug Substance ◽  
Manufacturing Processes

Selection of Manufacturing Processes and Design Considerations

2014 ◽  
pp. 133-158
Author(s):  
Anil Mital ◽  
Anoop Desai ◽  
Anand Subramanian ◽  
Aashi Mital
Keyword(s):  
Manufacturing Processes ◽  
Design Considerations ◽  
Selection Of

Product and Factory Modeling for Production Rate Determination

1999 ◽  
Author(s):  
S. G. Karthik ◽  
Edward B. Magrab
Keyword(s):  
Production Rate ◽  
Lead Time ◽  
Design Stage ◽  
Manufacturing Processes ◽  
Assembly Structure ◽  
Secondary Manufacturing ◽  
Relationship Of ◽  
The Relationship ◽  
Selection Of ◽  
Made In

Abstract An intelligent graphical user interface that captures a product’s functional and assembly structure and the factory that will make it are described. The results are then used to evaluate a factory’s production rate for the product. The program requires the product to be either a functionally uncoupled or decoupled design. The interface then: (1) implements a visualization of the functionally decomposed product structure; (2) implements an abstraction of a factory; (3) automatically generates candidate primary manufacturing processes and materials that are compatible with each other based on a very small number of attributes; (4) enables the user to make Make/Buy decisions for the components comprising the product; (5) assists the user in the selection of secondary manufacturing processes that are compatible with the primary manufacturing processes and materials for parts made in-house, and specify the vendor and the supply lead time for outsourced parts; (6) enables the specification of alternate materials and manufacturing processes; (7) implements a visual representation of the assembly structure as specified by the user; and (8) partially automates the creation of the assembly structure, and assists in the selection of assembly methods that are compatible with the materials chosen. In addition, the program assists in the design for assembly by: (1) requiring the product development team to think about the assembly process early in the design stage; (2) providing a visualization of the relationship of all components comprising the product to its other components; (3) requiring the specification of the order in which they are to be assembled; and (4) requiring the selection of assembly processes that are compatible with each other and the materials chosen. It also requires the specification of the capabilities of the factory that is going to make one or more of the components of the product, and requires that Make/Buy decisions for the parts comprising the product be made.

Methods for Process Selection in Design

1990 ◽  
Author(s):  
K. Ishii ◽  
C. H. Lee ◽  
R. A. Miller
Keyword(s):  
Life Cycle Cost ◽  
Object Oriented ◽  
Manufacturing Processes ◽  
Future Challenge ◽  
Process Selection ◽  
Development Environment ◽  
Types Of Knowledge ◽  
Major Factors ◽  
Case Based ◽  
Selection Of

Abstract This paper describes our proposed methodology for process selection that applies to the early stages of product design. We focus on net-shape manufacturing processes and identify the major factors that affect the selection of an appropriate process. The sequence at which designers typically make decisions depends largely on the nature of the product and the development environment. Thus, a versatile methodology should consider all the factors simultaneously in assessing the suitability of the candidate processes. The paper describes three types of knowledge that represent the compatibility of various processes to a given set of specifications: a) Case-based knowledge, i.e., templates of good, bad, and poor combination of decisions, b) Ordinal relationships among candidate processes based on interval analysis of cost, and c) Life-cycle cost estimate. Each type of knowledge gives an evaluation of suitability (compatibility) of candidate processes. Our future challenge lies in combining these measures at various stages of product development. Our initial studies on relationships between process selection and influencing factors lead to a HyperCard stack which stores information in an object-oriented fashion. This stack contains information which is the basis for our future computer-aid for process selection.

Selection of the best phase transformation model for optimization of manufacturing processes of pearlitic steel rails

2019 ◽  
Vol 19 (2) ◽  
pp. 535-546 ◽  
Author(s):  
Roman Kuziak ◽  
Valeriy Pidvysots’kyy ◽  
Monika Pernach ◽  
Łukasz Rauch ◽  
Tomasz Zygmunt ◽  
...  
Keyword(s):  
Phase Transformation ◽  
Pearlitic Steel ◽  
Transformation Model ◽  
Manufacturing Processes ◽  
Selection Of

scholarly journals Assessment and Comparison of Various MCDM Approaches in the Selection of Manufacturing Process

2020 ◽  
Vol 2020 ◽  
pp. 1-16 ◽  
Author(s):  
Atef M. Ghaleb ◽  
Husam Kaid ◽  
Ali Alsamhan ◽  
Syed Hammad Mian ◽  
Lotfi Hidri
Keyword(s):  
Decision Making ◽  
Computational Complexity ◽  
Manufacturing Process ◽  
Group Decision ◽  
Die Casting ◽  
Multicriteria Decision Making ◽  
Sand Casting ◽  
Manufacturing Processes ◽  
Alternative Processes ◽  
Selection Of

The selection of manufacturing processes for a given application is a complex problem of multicriteria decision-making although there have been several different approaches that can be utilized to select a suitable alternative. However, identifying appropriate multicriteria decision-making approach from the list of available methods for a given application is a difficult task. This work suggests a methodology to assess different selection approaches, which are the technique for order of preference by similarity to ideal solution (TOPSIS), analytic hierarchy process (AHP), and VIKOR: stepwise procedure. This valuation was done depending on the following factors: number of alternative processes and criteria, agility through the process of decision-making, computational complexity, adequacy in supporting a group decision, and addition or removal of a criterion. A case study in this study was presented to analyse the evaluation methodology. The criteria used to evaluate and identify the best manufacturing process were categorized into productivity, accuracy, complexity, flexibility, material utilization, quality, and operation cost. Five manufacturing processes were considered, including gravity die casting, investment casting, pressure die casting, sand casting, and additive manufacturing. The results showed that each approach was suitable for the problems of manufacturing process selection, in particular toward the support of group decision-making and uncertainty modelling. Manufacturing processes were ranked based on their respective weights for AHP, TOPSIS, and VIKOR, and sand casting is the best. In terms of computational complexity, the VIKOR method performed better than TOPSIS and AHP. Moreover, the VIKOR and TOPSIS methods were better convenient to the selection of manufacturing processes for agility during the process of decision-making, the number of alternative processes and criteria, adequacy in supporting a group decision, and addition or removal of a criterion.

ShapeSift: Suggesting Sustainable Options in Design Reuse From Part Repositories

2013 ◽  
Author(s):  
Devarajan Ramanujan ◽  
William Benjamin ◽  
William Z. Bernstein ◽  
Niklas Elmqvist ◽  
Karthik Ramani
Keyword(s):  
Decision Making ◽  
Environmental Sustainability ◽  
Manufacturing Processes ◽  
Design Reuse ◽  
Exploration Process ◽  
Sustainability Indicator ◽  
Selection Of

ShapeSift is a framework for supporting sustainability-based decision making during selection of similar previous designs from part repositories. Our framework is designed for 3D part repositories that contain metadata pertaining to materials and manufacturing processes as well as the functionality of a given part. To demonstrate the usefulness of the proposed framework we develop an example multi-dimensional visualization that encodes part similarities as well as a calculated environmental sustainability indicator. This visualization is incorporated in a prototype interface that focuses on enhancing the intuitiveness of the exploration process by the use of sketch-based retrieval.

Sign in / Sign up

Export Citation Format

Share Document